The present invention relates to barrier methods of human contraception and prevention of sexually transmitted diseases (STDs). More specifically, the invention relates to female condoms, i.e., condoms worn by a woman rather than a man.
Unintended pregnancy and STDs present serious health and social consequences for individuals and society at large. Known prevention and protection measures have reduced these problems to some extent. Male condoms are a well known form of a barrier device that provide varying degrees of protection against unintended pregnancy and STDs. Male condoms, however, generally require the male partner to initiate use after an erection has been attained, thus frequently causing an awkward disruption of intimacy and foreplay. Additionally, many women would prefer not to have to rely on their male partner to provide their protection. Male condoms are disliked for a variety of additional reasons, including reduced sensation for the male partner.
Problems associated with male condoms have led to the development of various forms of female condom that a woman can pre-place in her vagina before intercourse. Unlike a conventional diaphragm or cervical cap, which covers only a region of the vagina near the cervix or the cervix itself, known female condoms generally provide a tubular receptacle extending along the length of the vaginal canal, thereby fully encompassing an inserted penis and affording increased protection. Such devices advantageously empower a woman to protect herself from unintended pregnancy and STDs, without reliance on the male partner.
While known female condoms provide a level of protection and advantage over conventional male condoms, they do not present an ideal solution. Several problems can be identified. Some female condoms are difficult to use and others may be uncomfortable for some women. Both of these problems may reduce the pleasure of intercourse for both the male and the female partner. With many designs, the outside portion of the female condom may shift and twist excessively prior to and during initiation of intercourse. This may require the woman to hold the outside portion with one or both hands during penis insertion, which can be disruptive and awkward. A related problem of known female condoms is a lack of stability of the condom within the vaginal canal. The condoms may move around, and fall partially out, or a portion intended to remain outside of the vagina may be pushed inside. This lack of stability compromises barrier protection, and may make both partners feel nervous and insecure during intercourse.
Hessel U.S. Pat. Nos. 5,490,519 and 5,623,946 disclose tubular devices worn by a female for protection against transfer of infectious matter during sexual intercourse. This general type of condom is available commercially as the REALITY® condom. As shown in FIG. 1 of the present application, these tubular devices have an open end 1 defined by a first ring 3, and a second closed end 5 to be positioned at the distal end of the vagina. The internal tubular portion of the condom is designed to be retained by retaining means positioned at closed end 5, e.g., a second ring 7. Second ring 7 is oriented at an acute angle relative to first ring 3, and is designed to wedge or anchor around the cervix a manner similar to a diaphragm. In use, this ring may slip away from its anchor point and permit a portion of the front part of the condom to hang or dangle outside of the woman user. Also, because the retaining means acts at the distal end of the vagina, security of the first (outer) ring 3 is dependent on the length of the vaginal canal.
Evans et al. U.S. Pat. No. 4,945,923 also discloses a tubular contraceptive device to be worn by a woman. The device includes an outer ring and an inner ring positioned at a closed distal end of the device. The inner ring is, like the Hessel devices, designed to anchor the bottom end of the device around the cervix of a user. It is similarly susceptible to slippage from its cervical anchor point, and twisting or displacement during use.
Another type of female condom, shown in FIG. 2, is commercially available as the REDDY® condom. The REDDY® condom is manufactured in India and has a design generally similar to the REALITY® condom. An outer (proximal) ring 9 of the REDDY® condom is shield-shaped, and retention of an inner pouch 11 is provided by a sponge 13 that is intended to lodge somewhere in the distal region of the vagina near the cervix. The REDDY® condom likewise may lack stability within the vaginal cavity.
Another known type of female contraceptive device is a panty condom 15 as shown in FIG. 3. While providing external stability, these devices do not adequately address the need for stability of the condom pouch within the vagina. A pouch portion 17 that is inserted into the vagina may pull inside out, or twist or turn, which can adversely affect male partner sensation and compromise barrier protection. Additionally, with known panty condoms, air tends to be pumped into the vaginal cavity during intercourse. This can be noisy and uncomfortable for the woman. After intercourse, the devices may turn inside out during withdrawal, thereby making a mess and increasing the potential for disease transmission and unintended pregnancy. Additionally, the panty configuration may be objectionable to users for aesthetic reasons.
Artsi et al. U.S. Pat. No. 5,515,862 discloses a female condom generally similar to the aforementioned panty arrangement. The device has an extensive external shield which is adhesively applied to cover pubic, abdominal, groin, thigh and anal regions, and a flexible tube extending from the shield to a closed end. Multiple rings are positioned along the length of the tube. One ring is used at the closed end to anchor around the cervix, similar to a diaphragm, and additional rings placed along the length of the tube are intended to lodge against the muscular tissue of the vaginal passage, to prevent slippage of the tube along the length of the vagina during use. The disclosed “semi-rigid” intermediate rings may to some extent improve stability of the tube in the vagina canal, yet no guidance is provided with respect to a positioning, sizing or configuration of the intermediate rings to maximize internal/external condom stability. Additionally, multiple rings positioned along the length of the condom may be encountered by a man's penis during intercourse, thus causing discomfort to the male partner.